Effect of Rosuvastatin on endothelial function in patients with diabetes and glaucoma

• Conditions: volunteers with Diabetes type I or II and volunteers with Glaucoma are includedGlaucoma; MedDRA version: 9.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes); MedDRA version: 9.1Level: HLTClassification code 10018305Term: Glaucomas (excl congenital)

• Registration Number: EUCTR2008-006937-28-AT
• Lead Sponsor: niversitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Cohort I
- Men and women aged over 18 years
- subjects with both hypercholesterolemia and normal lipid profile will be included
- Diabetes type I or type II. Only patients with no signs of diabetic retinopathy (level 1) or patients with mild or moderate diabetic retinopathy will be included. Level of diabetic retinopathy will be assessed according to the modified Airlie House classification (1991)
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 6 Dpt.

Cohort II
-Men and women aged over 18 years
- subjects with both hypercholesterolemia and normal lipid profile will be included
- Open angle glaucoma defined as pathological optic disc appearance and characteristic visual field loss. Visual field loss is defined as having a glaucoma hemifield test outside normal limits and /or a CPSD with P < 0.05 (Keltner et al. 2003)
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 6 Dpt
- sufficiently controlled intraocular pressure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
-Symptoms of a clinically relevant illness in the 3 weeks before the first study day
-Previous or current treatment with statins
-Current treatment with fibrates
-History or presence of renal failure, creatine kinase (CK) and lactic dehydrogenase (LDH) above normal levels
-History or presence of hepatic dysfunction, including increase of liver enzymes
-Patients with known hypersensitivity to the study drug or any ingredients
-Patients with or with a history of myopathy
-Systemic treatment with oral anticoagulants except low dose aspirin
-Blood donation during the previous 3 weeks
-Ametropy more than 6 dpt
-Presence of intraocular pathology other than non proliferative diabetic retinopathy for cohort I and glaucoma for cohort II
-Ophthalmolgical surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy) within the last 6 months before the study
-History or family history of epilepsy
-Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified